China NMPA Product Recall - Soft hydrophilic contact mirror

Bausch & Lomb Incorporated initiated a Class III voluntary recall for its soft hydrophilic contact lenses, as reported by the National Medical Products Administration (NMPA) on June 21, 2019. The recall stems from a typographical error in the product packaging and instruction manual, where the refractive index value was incorrectly listed as "1.4306" instead of the correct "1.4036". This issue affects products manufactured between January 2016 and August 2018, totaling 468,013 boxes sold in China. Despite the error, Bausch & Lomb clarified that the incorrect refractive index does not impact product fitting or consumer use, as this specific value is not utilized during these processes. The correct refractive index is documented in the product's registration certificate and technical requirements. To address the violation, Bausch & Lomb is required to promptly revise the instruction manuals for all newly manufactured soft hydrophilic contact lenses to display the correct refractive index of 1.4036. Furthermore, for the products already distributed, the company must issue a public warning to customers and consumers through its official China website (www.bausch.com.cn), informing them of the discrepancy and referring to the revised instruction manual if needed. Notably, this recall does not necessitate physical actions such as product replacement, physical recall, or relabeling, focusing instead on informational correction.